AccessGUDID - DEVICE: Sprint 100 (08592654276952)

GUDID

Device Identifier (DI) Information

Brand Name: Sprint 100
Version or Model: 1ES15409-275
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: L I N E T spol. s r.o.

Primary DI Number: 08592654276952
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 644544504 *Terms of Use

Device Description: The sprint stretcher transport bed in its basic option used for transport and for x-ray scanning is designed for the transport critical patients being admitted in emergency conditions.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35892	Hospital stretcher, manual	A manually-operated device consisting of a platform mounted on a wheeled frame designed primarily to facilitate easy transport of a recumbent patient within a healthcare facility; it may include side rails, supports for fluid infusion equipment, and patient securement straps. The device may also be used as a treatment table (e.g., in an emergency, recovery, or labour room), or as a bed in some intensive and specialized care units or under high patient census conditions (e.g., disasters).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPO	Stretcher, Wheeled

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5f8845b0-31ec-4bc5-8e04-8c6b77827f8f
Public Version Date: April 09, 2021
Public Version Number: 1
DI Record Publish Date: April 01, 2021